European Stars and Stripes (Newspaper) - December 3, 1991, Darmstadt, Hesse                                Exorbitant costs hinder experimental cancer treatment new York Timet Marie Mccook with or. Edward a. Stadtmauer had full coverage for her $100,000 operation. By Erik Eckholm the new York times last fall two months after the birth of her second child. Marie Mccook of Philadelphia discovered she had breast cancer that had spread into her neck. Her prognosis was poor but her doctors told her she was a suitable candidate for a dangerous unproved and costly therapy under study a Bone marrow transplant that would allow them to bombard her body with huge otherwise lethal doses of anticancer drugs. She grasped the slender Reed. Quot i feel it has Given me an Opportunity at a possible cure Quot Mccook 35, said of the $100,000 procedure. It was performed this Spring at the University of Pennsylvania cancer Center and while her cancer has melted away she will not know if she is cured for years. The Bills were paid by her health insurance company which is supporting the study. Evelyn Harper 47, with two children Learned last fall that her breast cancer had invaded her eyes and liver. A resident of the Virgin islands she sought treatment in los Angeles where doctors said she too should consider a marrow transplant. But her insurer like Many around the country said it would not cover an experimental therapy. In february she appealed sending reams of data provided by her doctors arguing that the procedure might give her a 20 percent Chance of surviving cancer free for years. At the end of May the Appeal was denied by then the cancer had spread too widely to consider a transplant. Quot that might not have sounded like a big Chance of Success but its a lot better than nothing Quot said her husband Dennis Harper. Quot it seems like the insurance company holds you off As Long As possible waiting until its too late for a transplant. That s not  whether insurers should pay for marrow transplants has already become tinder for bitter lawsuits poignant talk shows and an emerging political movement of breast cancer patients. The debate exemplifies the wrenching issues that May increasingly bedevil american Medicine in an Era of fast changing enormously expensive neat ments and rising concern about costs. Health experts and government leaders As Well As a usurers Hope to tame runaway medical expenses i rough More stringent assessment of new treatments and by weighing their benefits and costs. The concepts sound sensible and uncontroversial a until they Are applied to real people especially with life threatening diseases like breast cancer and to promising treatments being urgently refined like marrow transplants. Grueling ordeals that put patients through at least three harrowing weeks of hospitalization transplants have already proved useful against certain cancers of the blood and insurers generally pay in those cases. Doctors Are now trying the therapy in patients with several other kinds of cancer including ovarian testicular and especially breast some patients have shown encouraging responses Many have not and the mortality rate from the procedure itself while improving is still 5 percent or More. All the researchers agree on the need for More research. But they put different shades on the same skimpy facts. Quot for the right patient i think it should be considered a therapeutic option a said or William p. Peters director of the Duke University medical centers marrow transplant program a Leader in research on transplants for breast cancer and a critic of insurance companies that refuse to pay when the procedures Are performed at experienced centers. Other experts Are sceptical. Quot we have raised the Public s expectations far beyond what is supported by the published data a or i Craig Henderson director of the breast evaluation Center of the Dana Farber cancer Institute in Boston wrote in the journal of the National cancer Institute this summer we have no evidence As of yet that any patient will be cured by this therapy who would not have been cured by More conventional  there a a whole list of things that could go wrong and yes it scared me. But i also have two Small children and the Chance of not being Here in 10 years also scares  Marie Mccook hundreds of women with breast cancer this year will endure the transplants and accompanying blasts of drugs researchers believe at least 10.000 women a year of the More than 40.000 who die from breast cancel annually May be Good candidates if the procedure is shown to help More than it hurts. Most women whose cancer is caught in Early stages Are cured with conventional treatments including removal of the cancerous Lump or the entire breast along with drug therapy and radiation. For them there is no reason to take on the risk and travails of a marrow transplant Many More women Are ruled out As transplant candidates by age and condition. Because it is so demanding on the body the procedure is Seldom tue on women older than about 55, or on those with other medical problems firm answers about effectiveness Are several years away controlled clinical trials comparing patients receiving transplants with similar women receiving conventional chemotherapy have just begun. The procedure is becoming safer and less a expensive but even at _ Best research suggests it will never offer a miraculous cure for patients with advanced breast cancer Only raise their Odds of survival. For advanced breast cancer it appears that transplants will at Best keep 10 percent to 20 percent of the women cancer free said or Edward a. Stadtmauer of the University of Pennsylvania cancer Center who is treating Mccook in a study comparing transplants with traditional drug therapy. And that Success rate May fall he said As More patients Are followed for More years. Quot that still would be wonderful a he said. Quot but we also have to look at Quality of life toxicity and costs i have to say i still done to know which group in the study is going to do better there is truly no right answer in 1991.�?� with known therapies offering Little some patients see the unknown m a dil Terent Light. There s a whole list of things that could go wrong. And yes. It scared me Quot Mccook said. Quot but i also have two Small children and the Chance of not being Here in 10 years also scares me Quot insurance companies have Long said they do not cover unproved therapies but they have often paid Lor innovative unapproved uses of cancer drugs in decades past too they started paying with Little question for costly new procedures like coronary bypass operations that were widely adopted with Little evaluation but today expensive new procedures receive much closer scrutiny the official position of the insurance Industry on transplants is Clear enough. Quot we Are not saying this is Loo expensive and it  be covered Quot said Naomi Aronson director of technology assessment with the Blue Cross and Blue shield association in Chicago. Quot we Are saying that procedures need to be evaluated so that precious health care resources can be used for things that Are effective Quot if studies prove that transplants improve survival Aronson said the companies will pay to Speed the search for answers and perhaps tend off lawsuits Many Blue Cross affiliates and in the Philadelphia area . Healthcare a Large health maintenance organization have agreed to contribute to the costs of patients receiving transplants in certain clinical trials. In practice,.after hearing pleas or threats from doctors or lawyers Many insurers Are paying transplant Bills for some breast cancer patients but Many Loo Are denying coverage recently some insurers have begun writing policies that specifically exclude coverage of marrow transplants for breast cancer. Cancer researchers As Well As desperate patients Aie angry. Quot it s unfortunate because basically they Are holding transplants for breast cancer up to a dil Terent stand id than other costly procedures a said or. Karen h Antman director of the transplant program at the Dana Farber a Ancer Institute. Insurance officials deny they have a double Standard. Quot it will be impossible to do studies unless patients have coverage Quot Antman added. Military hospitals also face dilemma by Chuck Vinch Washington Bureau the . Military is wrestling with the same ethical and budgetary questions As civilian doctors Over a costly and As yet unproven a cancer treatment. A we re not talking cure Here a we re talking about extending survival for some people a said or. It col Jim Thompson chief of Haematology and oncology at the air Force s Wilford Hall medical Center at Lackland fab Texas a so if we re not curing people and if 10 percent of the patients die from the procedure itself is it really an improvement Over the current Standard of treatment Quot the procedure is based on the simple idea that very Large doses of chemotherapy can More effectively kill cancerous tumor cells. The problem is that such concentrated doses also kill the Bone marrow cells that produce fresh blood and thus kill the patient. Auto logos Bons marrow transplants try to overcome that by removing some of the marrow cells freezing them and transplanting the cells Back into the patient after chemotherapy. The army has done 18 such transplants at Walter Reed since november 1990 and More than 100 at its Brooke army medical Center at fort Sam Houston Texas since 1984 the air Force has done More than 180 transplants at Wilford Hall since 1983. The procedures also Are covered by the civilian health and medical program of the uniformed services the Pentagon a private health insurer. The Navy does not perform the procedure but refers prospective patients to champs said Liz Lavallee a spokeswoman for the Navy Bureau of Medicine and surgery. If champs coverage is denied costs for the transplant May be covered by supplemental Navy funding on a Case by base basis with the procedure being done in the private sector or at an army or air Force facility Lavallee said. The military s Success rate with the transplants generally tracks results in the civilian world so far a Aboul 20 percent of patients respond very Well about 10 percent die from the procedure itself and the rest experience Short term remission at Best. Or. It. Col Louis Diehl chief of Haematology and oncology at Walter Reed said advocates of the procedure say proof of its effectiveness is shown by the fact that 20 percent to 25 percent of patients who have it remain disease free for two years or More Quot but is that the definitive yardstick a Diehl said. Quot this is the dilemma with investigative procedures a there a no Point at which anyone can stand up and proclaim that something is no longer experimental but should be considered the Standard of  breast cancer for example is curable by other Means up to 80 percent of the time if diagnosed Early enough. The Issue then becomes whether Auto logos marrow transplants would significantly enhance the current Success rate Thompson said. What military physicians Are learning is that Auto logos Bone marrow transplants can be effective if patients Are carefully selected. Much seems to depend on the Type of cancer the age of the patients and How advanced their disease is. Quot this is a highly toxic treatment a Thompson said. Quot someone who is 55, smokes maybe has a history of heart disease is not a Good  while the process of developing and approving experimental procedures for the military health care system often seems vague military medical officials say that is Only to be expected when dealing with something that is after All experimental. Particularly with Cancar treatments substantive and useful results from clinical trials often take years to come together and those results must be weighed against such issues As How Many patients will Benefit and costs for treatment. Quot we re constantly reviewing our investigative research protocols for experimental procedures a said or. It. Col Lloyd Lippert chief of research operations for the department of clinical investigations at Walter Reed. Experimental procedures generally begin to make their Way into the military system at the ground level through military doctors themselves said maj. Rocky Calcote medical research program officer for the air Force surgeon general. Quot almost All physicians belong to various professional organizations and associations Quot Calcote said Quot they hear about programs in the civilian world and take it Back into the air Force and then it gets discussed  from that Point its a collaborative Effort that ultimately reaches the very top Levels of the service medical departments. Quot in the end the surgeon general looks at the scientific data and weighs the pros and cons of getting the service involved Quot Calcote said. Quot will it Benefit our patients which ones will it Benefit can our system handle it a once a Green Light is Given to explore the potential of an experimental procedure the service designates one or two of its Premier medical facilities to do the research As the army and air Force have done with Auto logos Bone marrow transplants. There Are few formal guidelines about determining which service lays the groundwork for the military s involvement with a particular procedure. Quot we try not to duplicate efforts Quot Calcote said pointing out that the army is usually Given the Lead on developing and testing vaccines for example. Quot but the air Force getting out in front on Auto logos marrow transplants happened More or less by  that situation will change under a recent reorganization of the military medical system that gives the assistant Secretary of defense for health affairs greater authority to manage service research efforts said Pentagon spokeswoman Susan Hansen. Research funding is another key Factor in the development of experimental procedures. Quot expense is a big Issue in the medical Community now and it goes to the heart of How we As a nation want to Deal with health care a Thompson said. Quot it s getting More difficult to find someone willing to pay for investigative  As the military downsides that Issue will become even More prominent. Wilford Hall already has a $25 million shortfall in its operations and maintenance accounts Thompson said. While the army and air Force Are set on establishing Auto logos Bone marrow transplants As fixtures in their health care programs whether they will get involved in experimental procedures in the future a at least As Early in the research stage As they sometimes do now a remains to be seen. Quot the fact is the military budget is shrinking a Thompson said. Quot How that will ultimately play out for military medical research no one  Quot if someone High up makes a decision on How much we re going to spend on medical care there s nothing i can do about that Quot said Walter Reed s Diehl. Quot but As an individual physician i m going to do everything i can to help my  reluctant to cover unproven procedures insurers generally wait until the Success of clinical trials Are Well established and procedures Are widely considered Safe and effective before agreeing to cover them. For example the civilian health and medical program of the uniformed services the Pentagon s private health insurer agreed to share costs for heart and lung transplants Only this year. Champs decided to cover beneficiaries for Auto logos Bone marrow transplants which have been done in military facilities since 1983, four years ago and Only for certain types of cancer said Dave Potts a champs spokesman. Cancers now covered by the program include Lymphoma Hodgkin a disease Neuroblast Oma and several types of acute leukaemia he said. Champs officials look at a number of factors when considering coverage for a new procedure including whether a recognized bodies such As the National cancer Institute Sanction the procedure As Safe and effective. A the food and drug administration has approved the devices or drugs involved. A other third party insurers such As medicare and Blue Cros Blue shield cover it. In considering new procedures. Champs works closely with the National institutes of health which has agencies dedicated to evaluating new medical technologies and treatments Potts said. In an Effort to strengthen the Way in which decisions Are made regarding coverage of various procedures the champs program development office recently formed an advisory panel to gather advice from the military services clinical consultants. The panel meets quarterly to discuss issues related to champs policy including research and development initiatives both in the military and the private sector a Chuck Vinch Page 14 a the stars and stripes tuesday december 3.1991 the stars and stripes a Page 15